FDA DeviceClass IINotable
FDA Recall: Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. A
Description
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Remedy
220 units
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